Source:

Pejovic
NJ
,
Höök
SM
,
Byamugisha
J
, et al
.
A randomized trial of laryngeal mask airway in neonatal resuscitation
.
N Engl J Med
.
2020
;
383
(
22
):
2138
-
2147
; doi:
https://doi.org/10.1056/NEJMoa2005333

Investigators from multiple institutions conducted a randomized trial to assess the effect of 2 different airway devices on newborn resuscitation outcomes. Newborns born at the study hospital in Uganda at ≥34 weeks’ gestation and birth weight ≥2,000 g who required positive-pressure ventilation (PPV) at birth (defined as not breathing after drying, stimulation, and assessment after delivery) were eligible. Demographics and clinical characteristics of enrolled newborns were collected at baseline.

Newborns were randomized to receive bag-and-mask ventilation from a midwife using either a laryngeal mask airway (LMA) or a face mask. Inflations with either device were administered with ambient air with a self-inflating bag. Midwives were instructed to continue ventilation with the assigned device for 3 minutes, and if ventilation was inadequate, to reposition the device before considering a switch to the other device. Newborns with a 5-minute Apgar of <7 and persistent respiratory distress were transferred to the study hospital’s NICU.

Standard practice at the study hospital is to have midwives resuscitate infants, and all midwives received a 1-day training session prior to the study to practice face-mask ventilation as well as to learn how to use LMAs. Three successful LMA insertions in mannequins were required. Repeated on-site training occurred throughout the study.

The primary outcome was death within 7 days or admission to the NICU with moderate-to-severe hypoxic-ischemic encephalopathy (HIE) at day 1 to 5 of hospitalization, defined by using a validated HIE tool. Secondary outcomes included pre-defined potentially intervention-related adverse events. The investigators used an intention-to-treat analysis to compare outcomes between the 2 groups after adjusting for potential confounders.

There were 1,154 newborns included in analysis, 563 of whom were in the LMA group. There were no differences in baseline demographic and clinical characteristics between the 2 groups except for more male infants in the LMA (vs face-mask) group. Crossover to the other device occurred in 3.5% of the LMA group and 10.9% of the face-mask group (relative risk [RR], 0.32; 95% Confidence Interval [CI], 0.2, 0.53). A primary outcome event occurred in 27.4% of the LMA group and 24.4% of the face-mask group (adjusted RR, 1.16; 95% CI, 0.90, 1.51). There also were no significant differences in adverse events between the 2 groups.

The investigators conclude that use of LMA is not superior to face mask in delivering PPV to newborns in a low-income country.

Dr Mintzer has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.

Inadequate respiration at birth, or perinatal asphyxia, is an important contributor to infant mortality rates, especially within resource-limited environments. Therefore, providing appropriate resuscitation of newborns is an essential step toward reducing morbidity and mortality among the worldwide neonatal population. Since 2010,...

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